Assessment of the Efficacy of a Fatigue Management Therapy in Schizophrenia

University Hospital, Montpellier200 enrolled

Overview

Fatigue is commonly experienced in numerous pathologies, including schizophrenia. Research has shown that chronic fatigue can exacerbate clinical symptoms. Several evidence-based interventions for fatigue syndrome have been shown to be effective in other medical conditions, but up to this date no research has assessed interventions in fatigue management within psychotic populations. The aim of this study is to evaluate (in a multisite single blind randomized clinical trial) the efficacy of a cognitive-behavioral therapy (CBT) intervention of fatigue management in people diagnosed with schizophrenia. Secondary objectives include the examination of changes in fatigue scores as well as clinical symptoms, physical \& cognitive functioning, quality of life at 9-month post CBT intervention. Another aim in this study is to assess - MICROBIATE The investigators hypothesize that following the CBT treatment intervention, patients will demonstrate reduced level of fatigue. No change in the severity of fatigue is expected in the group receiving treatment as usual.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Schizophrenia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Aged between 18 and 60 years, 2. patients with a diagnosis of schizophrenia according to DSM 5 validated after a clinical evaluation by one psychiatrist investigators, 3. patients with a score at the 4th subscale of "Multidimensional Fatigue Inventory " greater or equal to 10 4. patients with a follow-up in a day hospital at inclusion, 5. subjects must be able to attend all scheduled visits and comply with all trial procedures, Non inclusion criteria: 1. subject unable to read or/and write French, 2. planned long-term stay outside of the study region that prevents compliance with the visit plan, 3. patients with a history of severe brain trauma, 4. patients with a history of neurological pathology, 5. patients pregnant or breast-feeding 6. patients deprived of liberty 7. patients participating in another ongoing biomedical study 8. patients not affiliated with a French social security scheme or beneficiary of such a scheme 9. Absence of signed informed consent form by the patient and the patient's tutor if he has one

Outcomes

Primary Outcomes

Multidimensional Fatigue Inventory (MFI)

MFI - self-assessment instrument with 20 items including 5 dimensions: General, Physical, and Mental Fatigue, Reduced Motivation and Reduced Activity

Time frame: Change between baseline and 3 months later (corresponding to the end of the treatment intervention)

Secondary Outcomes

Positive and Negative Syndrome Scale (PANSS)

PANSS - 30 item scale assessing level of symptomatology (positive, negative, general psychopathology) in psychotic disorders

Time frame: baseline - 3 months - 9 months

Clinical Assessment Interview for Negative Symptoms (CAINS)

CAINS - semi-structured interview measuring level of severity of negative symptoms

Time frame: baseline - 3 months - 9 months

Calgary Depression Scale for Schizophrenia (CDSS)

CDSS - 9 item scale assessing level of depressive symptomatology in schizophrenic populations

Time frame: baseline - 3 months - 9 months

Berlin Questionnaire (BQ)

BQ- questionnaire consisting of 3 categories related to the risk of having sleep apnea; snoring (section 1), daytime somnolence (section 2), and hypertension and BMI (section 3

Time frame: baseline - 3 months - 9 months

Idiopathic Hypersomnia Severity Scale (IHSS)

IHSS - self-report measure of 14 items assessing - hypersomnolence symptoms, consequences, and responsiveness to treatment

Time frame: baseline - 3 months - 9 months

Sleep Condition Indicator (SCI)

SCI - 8 item scale evaluating symptoms of insomnia based on DSM 5 criteria

Time frame: baseline - 3 months - 9 months

International Physical Activity Questionnaire short form (IPAQ)

IPAQ - surveillance tool assessing levels of physical activity in patients with schizophrenia

Time frame: baseline - 3 months - 9 months

Quality of life (S-QoL)

(S-QoL) - self-assessment questionnaire assessing health related quality of life in schizophrenic populations

Time frame: baseline - 3 months - 9 months

Functional Remission of General Schizophrenia (FROGS)

FROGS - 19 item questionnaire assessing level of functional remission in schizophrenic populations

Time frame: baseline - 3 months - 9 months

Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR)

IMI-SR - self-report scale with 21 items evaluating intrinsic motivation in schizophrenic populations

Time frame: baseline - 3 months - 9 months

French National Adult Reading Test (fNART)

fNART - test used in assessing intellectual levels within French speaking populations

Time frame: baseline - 9 months

California Verbal Learning Test (CVLT)

CVLT - neuropsychological assessment evaluating episodic verbal learning and memory

Time frame: baseline - 9 months

Trail Making Test (TMT)

TMT - neuropsychological assessment evaluating executive functioning (attention, visual exploration, speed, mental flexibility)

Time frame: baseline - 9 months

Pedometer

Pedometer - electronic portable device - assessment of distance travelled -

Time frame: baseline - 3 months - 9 months (each time pedometer will be worn during one week)

Physical examinations (PE) and vital signs (VS)

PE includes - weight, BMI, abdominal perimeter VS includes: heart rate, and arterial blood pressure

Time frame: baseline - 3 months - 9 months

Blood samples

lipids, glycaemia, CRP (C-reactive protein)

Time frame: baseline - 3 months - 9 months

Microbial translocation

DNA extraction and analyze of LBP (Lipopolysaccharide Binding Protein), CD14s, l'I-FABP (fatty acid-binding proteins), zonulin, real-time PCR (polymerase chain reaction) analysis (DNA16s)

Time frame: baseline - 3 months - 9 months

Inflammatory status

GM-CSF (granulocyte-macrophage colony-stimulating factor), IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, TNF-α

Time frame: baseline - 3 months - 9 months

Letter-Number Sequencing subtest (LNS)

good predictor of fluid intelligence and strongly correlates with laboratory working memory measures.

Time frame: baseline - 9 months

Assessment of the Efficacy of a Fatigue Management Therapy in Schizophrenia

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts